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Thursday, September 14, 2017

A Seattle-based biotechnology company has received a new round of federal funding that will allow it to develop an in vitro testing system that mimics the human blood-brain barrier.

Nortis Inc. was awarded a $688,000 grant from the National Institutes of Health. The money will fund the third year of a Small Business Innovation Research fast-track grant from the National Institute of Neurological Disorders and Stroke.

Nortis has developed a proprietary 3D organ modeling system called ParVivo, which regulates the biological structure of human organs to allow accurate in vitro testing. The creation of a blood-brain barrier in vitro model could have a major impact on how drug companies test and develop treatments for neurological disorders like multiple sclerosis (MS).

Kevin Banks, PhD, Nortis’ vice president of sales and marketing, told MD Magazine that the technology dovetails nicely with efforts by drug developers to reduce animal testing and lower the rate of clinical trial failures. Banks noted that about 4 of every 10 Phase III studies are failures, a ratio that translates to expensive losses for drug companies.

“This is primarily due to efficacy and safety failures of the drugs, which have been primarily tested to that point using animal models and not human models,” Banks said. “The vision of using human 3D tissue models is to reduce clinical trial failure rates by using more relevant human models early in the drug development process.”

Drug delivery to the brain has long been a challenge for pharmaceutical companies. The blood-brain barrier, which is composed of endothelial tissue, protects the brain from foreign substances and helps maintain a constant environment, but the barrier also can stop drug molecules from getting into the brain.

Thus, companies developing drugs that require entry into the brain to trigger the desired pharmacological response have a major interest in efficiently and reliably figuring out how their therapies hold up against the barrier.

Abstract

OBJECTIVE: To examine safety and efficacy of use of a clitoral vacuum suction device (CVSD) versus vibratory stimulation (V) to treat orgasmic dysfunction in women with MS or SCI.

DESIGN: Randomized clinical trial.

SETTING: Two academic medical centers.

PARTICIPANTS: Thirty-one women including 20 with MS and 11 with SCI.

INTERVENTION: A 12-week trial of the use of a CVSD versus V MAIN OUTCOME MEASURES: Female Sexual Function Inventory (FSFI) and Female Sexual Distress Scale (FSDS).

RESULTS: 23 women (18 MS; 5 SCI) completed the study including 13/16 randomized to CVSD and 10/15 randomized to V. There was a statistically significant increase in total FSFI score (p=.011), desire (p=. 009), arousal (p=.009), lubrication (p=.008), orgasm (p=.012), and satisfaction (p=.049) and a significant decrease in distress as measured by FSDS (p=.020) in subjects using the CVSD. In subjects who used V, there was a statistically significant increase in the orgasm subscale of the FSFI (p=.028). Subjects using the CVSD maintained improvements 4 weeks after treatment.

CONCLUSION: CVSD is safe and overall efficacious to treat female neurogenic sexual dysfunction related to MS and SCI. V is also safe and efficacious to female neurogenic orgasmic dysfunction; however, results were limited to the active treatment period. Due to ease of access and cost, clinicians can consider use of V for women with MS or SCI with orgasmic dysfunction. CVSD is recommended for women with multiple sexual dysfunctions or for whom V is ineffective.

Abstract

OBJECTIVES: Cognitive impairment is common in multiple sclerosis (MS) and can have serious impact on social and occupational functioning. Natalizumab reduces relapse rates, magnetic resonance imaging (MRI) lesions, and progression of disability. Previous studies on cognitive functioning have not based inclusion on cognitive performance criteria. The aim of the present study was to determine any potential natalizumab-related cognitive effects on MS patients performing below normal limits on neuropsychological testing.

MATERIALS AND METHODS: Patients starting natalizumab (n = 21) and a quasi-control group of stable MS patients (n = 13) on first line disease modifying treatment were included following neuropsychological assessment demonstrating subnormal cognitive performance. Assessment, using ten cognitive variables, was repeated after 12 months. Symptoms of fatigue, anxiety and depression were also examined. Raw scores on the cognitive tests were transformed into Z-scores based on published age-corrected normative data.

RESULTS: Between-group analyses on difference Z-scores (baseline - follow-up) yielded significant results on Paced Auditory Serial Addition Test-2 (PASAT-2) (P = .008), with the natalizumab group showing larger improvement than quasi control patients. On PASAT-2, 28,5% from the natalizumab group demonstrated >1 SD improvement, indicative of clinically meaningful change, compared with none in the quasi control group. Patients receiving natalizumab showed within-group improvements on six of the ten cognitive variables. There were no group differences in symptoms of fatigue, anxiety or depression.

CONCLUSIONS: The results demonstrate improvement in information processing speed following 12-months of natalizumab treatment. The results are interpreted as reflection of anti-inflammatory properties of natalizumab rather than retest- or long-term restorative effects.

Abstract

Motor and cognitive disabilities are related to brain atrophy in multiple sclerosis (MS). 'Timed up and go' (TUG) has been recently tested in MS as functional mobility test, as it is able to evaluate ambulation/coordination-related tasks, as well as cognitive function related to mobility. The objective of this study is to evaluate the relationship between brain volumes and TUG performances. Inclusion criteria were a diagnosis of MS and the ability to walk at least 20 m. TUG was performed using a wearable inertial sensor. Times and velocities of TUG sub-phases were calculated by processing trunk acceleration data.

A stronger association with lower GM volume was observed for intermediate (ρ = 0.427, p = 0.001) and final turning (ρ = 0.390, p = 0.002). TUG is a useful tool in a clinical setting as it can not only evaluate patients' disability in terms of impaired functional mobility, but also estimate pathological features, such as grey atrophy.

Examining levels of the "sunshine vitamin" in the blood may help predict whether a person is at risk of developing the crippling condition which effects the central nervous system, according to a new study.

Around 100,000 people in Britain have MS which normally gets diagnosed between the ages of 20 and 40.

Study author Doctor Kassandra Munger, of the Harvard T.H. Chan School of Public Health in the United States, said: "There have only been a few small studies suggesting that levels of vitamin D in the blood can predict risk.

"Our study, involving a large number of women, suggests that correcting vitamin D deficiency in young and middle-age women may reduce their future risk of MS."

For the study, researchers used a repository of blood samples from more than 800,000 women in Finland, taken as part of prenatal testing.

The researchers then identified 1,092 women who were diagnosed with MS an average of nine years after giving the blood samples. They were compared to 2,123 women who did not develop the disease.

Deficient levels of vitamin D were defined as fewer than 30 nanomoles per litre (nmol/L). Insufficient levels were 30 to 49 nmol/L and adequate levels were 50 nmol/L or higher.

Wednesday, September 13, 2017

Depression and fatigue in multiple sclerosis (MS) share several features and have a similar longitudinal course, according to a recent study. However, using cut-off scores to define depression and fatigue, this study also found that non-depressed subjects with high fatigue may be at a greater risk for developing depression. MS subjects who completed a battery of patient reported outcome (PRO) measures including the CES-D and MFIS (n=435) were included in the analysis. Researchers found:

At baseline, 15% of subjects were classified as high on both depression and fatigue scales, 16% were classified as high on the fatigue scale only, and 9% were classified as high on the depression scale only.

There was a high correlation between CES-D and MFIS total scores (r=0.62).
High correlations were also observed between the somatic and retarded activity subscales of the CES-D and each of the MFIS subscales (r ≥0.60).

Subjects with high fatigue scores but low depression scores at baseline were more likely than subjects with low baseline fatigue and depression scores to develop high depression scores at follow-up.

The streamlined version of the Expanded Disability Status Scale (sEDSS) for multiple sclerosis (MS) had strong agreement and correlation with the existing EDSS and can provide a useful measure of disability in clinical practice, a recent study found. The EDSS was modified by eliminating maneuvers with no impact on function, consolidating redundancies, and simplifying scoring. This sEDSS was refined and preliminarily validated using a pilot cohort of 102 patients. Subsequently, the sEDSS was retrospectively validated using 968 patients from the CombiRx trial. Researchers evaluated correlation and agreement between each functional system as well as the overall sEDSS and EDSS. They concluded:

The sEDSS correlated strongly with the EDSS, both overall (Spearman’s rho = 0.93) and for each functional system (Spearman’s rho 0.65–0.97).
Correlation was slightly lower for functional systems where scoring was modified for consolidation and simplification.

Urinary urgency with incontinence is associated with recurrent falls in people with relapsing-remitting multiple sclerosis (RRMS) with mild-to-moderate disability, according to a recent study. 51 people aged 18 to 50 years with RRMS and mild-to-moderate disability (Expanded Disability Status Scale score ≤6.0) completed a self-report questionnaire regarding urinary incontinence, urgency, and frequency at baseline and then prospectively recorded their falls daily for 3 months using fall calendars. Participants were classified as recurrent fallers (≥2 falls) or non-recurrent fallers (<2 falls) for 1 regression model and then as fallers (≥1 falls) or non-fallers (no falls) for another regression model. Associations between baseline bladder dysfunction and faller status were assessed using logistic regression adjusted for the potential confounders of age, sex, and disability. Researchers found:

15 participants were recurrent fallers, 36 were non-recurrent fallers, 32 were fallers, and 19 were non-fallers.

After adjusting for age, sex, and disability, there was a significant association between urinary urgency with incontinence and recurrent falls in the 3 months after baseline.

Earlier this week I was moderating a group discussion among first
year medical students on a hypothetical medical case where a
physician prescribed his diabetic patient to lose fifty pounds and
exercise regularly in order to manage their chronic condition. The
students initially thought nothing of this statement, but as we
revisited the prescription, they realized the prescription was nonspecific
without an actionable plan to encourage adherence and
compliance of the diabetic patient to the treatment.

The physician did not give any practical
advice on nutrition, healthier food substitutes, best practices for weight loss, or where to
begin with exercise – thus, the hypothetical patient would have been left uninformed and
unfortunately be stuck with the same old habits. The students and I spoke about various
approaches to improving the prescription, for examplemotivational interviewing by the
physician as a means of identifying the patient’s values and desires, and using that
information to facilitate and encourage personal behavior change. I am the first to admit I
have always been biased to the positive possibilities of exercise on physical and mental
health, but for several years I saw exercise as a luxury, competing with the limited time I
had to spend on more important things. Fortunately, I had an academic coach use motivational interviewing to help me realize exercising was a cornerstone of my daily life,
and by exercising, I was more productive and effective when I applied myself to other
activities. This month there were several publications, not on motivational interviewing, but
on physical activity – suggesting exercise improves various outcomes in MS.Continue to read this article from The Accelerated Cure Project

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Tuesday, September 12, 2017

SILVER SPRING, Md. -- An FDA advisory committee voted 13-1, with one abstention, to recommend a new warning for gadolinium-based contrast agents (GBCAs) used in magnetic resonance imaging on Friday.

Specifically, the FDA's Medical Imaging Drugs Advisory Committee recommended that prescribing information should include "a warning for retention for all GBCAs with greater retention of all or some of the linear GBCAs compared to the macrocyclics in certain organs including the brain," and that "risk minimization steps" be taken for certain patient populations.

The FDA made a minor distinction between macrocyclic and linear GBCAs, noting the higher stability of the macrocyclics may cause them to "wash out" of the body; but the agency stressed that both agents leave behind deposits of gadolinium.

Agency leadership asked the committee for advice on how to weigh recent findings of gadolinium retention in the brain and other organs, and how to minimize potential risks moving forward. Virtually all committee members agreed that the evidence of retention in patients, to date, doesn't indicate a definitive causal relationship with an array of symptoms reported in the FDA's database and medical literature, beyond previously identified concerns for kidney patients (current labeling already includes a boxed warning and contraindications for this population).

In 2007, researchers uncovered a link between GBCAs and nephrogenic systemic fibrosis (NSF) -- a debilitating condition, that impacts the skin, muscles and internal organs and is sometimes fatal -- in kidney patients, however more recent evidence suggests patients without impaired renal function also show deposits of gadolinium in their central nervous system and throughout the body. As recently as June, researchers reported that gadolinium deposits were found in patients with normal brains -- previously intracranial abnormalities were seen as responsible for the agents clinging to neural tissues.

University of Southern California researchers are recruiting 400 Hispanics who have been diagnosed with multiple sclerosis in the past two years for a study about genetics’ and cultural perceptions’ effect on the severity of the disease.

More specifically, the Keck School of Medicine team will look at whether the stressful process of acculturation plays a role in ethnic Latinos engaging in behaviors that could worsen MS. Acculturation is the process of social, psychological, and cultural change that accompanies the blending of cultures.

Eventually the researchers hope to identify acculturation-related risk factors in multiple sclerosis.

American Hispanics come from diverse genetic and cultural backgrounds. The rationale behind the study is that finding genetic and socio-cultural factors that could affect the development of MS could help advance research in the field, according to a press release,

Researchers will assess whether Asian, Native American, European or African genetic markers in Latinos’ DNA correlate with the severity of their disease. The study will last two years.

The research is being funded by a National MS Society grant. Dr. Lilyana Amezcua of the Keck School of Medicine will be the study’s principal investigator.

In addition to USC, the research will conducted at the University of Miami, University of New Mexico, and the Caribbean Neurological Center in Puerto Rico. All participants will have to visit one of the study sites.

Participants will answer questionnaires about acculturation and the perception of their condition, watch a short film about MS, and provide a blood sample. Researchers will do a DNA analysis of the sample to learn more about participants’ ancestry.

For more information about the study, including how to participate, please contact Andrea Martinez of the Keck School of Medicine at andrea.martinez@med.usc.edu or call 1 (323) 442-6817.

Loss of the myelin protective layer of optic nerve cells due to inflammation causes optic neuritis. About 20 percent of MS have it, and optic neuritis is a symptom of disease progression in about 40 percent of patients. In most cases, symptoms persist, leading to visual impairment or blindness, along with pain.

Non-invasive optical coherence tomography (OCT) can help evaluate neurodegeneration of optic nerve cells. This imaging technique allows a three-dimensional evaluation of internal eye structures, including the thickness of the retina nerve fiber layer (RNFL). Previous studies have shown that MS patients may present progressive RNFL loss, but this can also be caused by optic neuritis.

The use of OCT has been proposed to distinguish MS subtypes and evaluate disease activity. However, little clinical data is available to validate OCT’s accuracy and potential as a diagnostic tool.

To find out more, a Danish research team conducted a long-term evaluation of structural and functional visual outcomes in MS patients with and without a history of optic neuritis.

The team studied 82 patients from Odense University Hospital — one of the largest hospitals in southern Denmark — who had been diagnosed with MS between 2000 and 2006. Participants provided optic neuritis history, while researchers tested visual acuity and color vision, and conducted a structural evaluation via OCT.

Researchers observed that patients with a history of optic neuritis had significantly more RNFL thickness loss than those without optic neuritis. They linked reduced RNFL thickness with a 1.56 times higher risk of optic neuritis development.

Courage is a recurring theme in my column. Many of us are familiar with the cowardly lion from the Wizard Of Oz. The lion itself is an animal known for its strength, beauty and valor. Thus, to think of a lion as a coward appears to be a contradiction in itself.

There is often a propensity to believe that fear is the antithesis of courage. This is untrue. Chronic illness and life itself have taught me that fear is a natural human response. It is a legitimate reaction. I recount the times I was told to be strong and/or brave, and I remember the anguish I felt if I was afraid.

“Strong” is regarded as a destination and if we fall short of this arrival, there must be something wrong with us. Society contributes to the disillusion by discouraging any display of fear and emotion. Emotionally honest people often are deemed as weak and incompetent. I’ve come to the realization that words intended to encourage also can have adverse effects. The expectation to “remain strong” at all times can put one under intense pressure, and is an impossible feat.

The reality is that even the strongest among us have weak moments, hours and days. We waiver between courage and fear. What we often are unaware of are the silent battles we face and fight everyday. Courage isn’t always bold; it can be hidden in the crevices of our mind, where we subconsciously make the decision to fight instead of flee. It is the little voice within that says we can make it when outside forces cause us to query if we will. It is in reminding ourselves that even in moments of weakness, we have courage.

I can be extremely hard on myself. MS and chronic illness have summoned my vigilance in such a way that I am always on high alert. I have to consciously remind my spirit that I am entitled to weak moments without guilt or shame. I am allowed to be afraid. You are, too. It is my belief that I display courage each time I don’t allow my fear to engulf or stunt me. My courage lies in continuing the journey. It lies in the simple act of wiping the tears I cry in private. It is the hope that flickers when the light is hard to see.

The cowardly lion eventually found courage within the depths of his being, and he was brave despite all that he feared. This, too, is where our courage resides. Courage comes from within and we all possess it. The mere act of admitting our fears and flaws are acts of courage, and we choose it more often than we know.

MS will continue to muster your courage. The intent of this week’s column is to remind you that strength is not measured by what you appear to be on the outside and how well you appear to hold it together. There is courage in falling apart, picking up the pieces and knowing that you will continue to fight the good fight.

SYMPTOMS of MS

In multiple sclerosis , damage to the myelin in the central nervous system (CNS), and to the nerve fibers themselves, interferes with the transmission of nerve signals between the brain and spinal cord and other parts of the body. This disruption of nerve signals produces the primary symptoms of MS, which vary depending on where the damage has occurred.

Over the course of the disease, some symptoms will come and go, while others may be more lasting.

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